Saxagliptin and metformin (Oral route)

Pronunciation:

Brand Names:

Dosage Forms:

Warnings:

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excessive alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Discontinue therapy and hospitalize the patient immediately for suspected lactic acidosis .

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Saxagliptin

Chemical—

Metformin

Uses of This Medicine:

Saxagliptin and metformin combination is used to treat high blood sugar levels caused by type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using saxagliptin and metformin will help to lower blood sugar when it is too high and help restore the way you use food to make energy.

Many people can control type 2 diabetes with diet alone or diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of saxagliptin and metformin combination you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

Saxagliptin and metformin combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of saxagliptin and metformin combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saxagliptin and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving this medicine. This medicine is not recommended in patients 80 years of age and older who have kidney problems.

Pregnancy—

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Acetrizoic Acid

Diatrizoate

Ethiodized Oil

Iobenzamic Acid

Iobitridol

Iocarmic Acid

Iocetamic Acid

Iodamide

Iodipamide

Iodixanol

Iodohippuric Acid

Iodopyracet

Iodoxamic Acid

Ioglicic Acid

Ioglycamic Acid

Iohexol

Iomeprol

Iopamidol

Iopanoic Acid

Iopentol

Iophendylate

Iopromide

Iopronic Acid

Ioseric Acid

Iosimide

Iotasul

Iothalamate

Iotrolan

Iotroxic Acid

Ioversol

Ioxaglate

Ioxitalamic Acid

Ipodate

Metrizamide

Metrizoic Acid

Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetazolamide

Alatrofloxacin

Balofloxacin

Bupropion

Carbamazepine

Ceritinib

Cimetidine

Ciprofloxacin

Clinafloxacin

Cobicistat

Crizotinib

Dabrafenib

Dichlorphenamide

Dofetilide

Dolutegravir

Eliglustat

Enoxacin

Eslicarbazepine Acetate

Fleroxacin

Flumequine

Gatifloxacin

Gemifloxacin

Grepafloxacin

Idelalisib

Levofloxacin

Lomefloxacin

Lomitapide

Mitotane

Moxifloxacin

Nilotinib

Norfloxacin

Ofloxacin

Pefloxacin

Piperaquine

Primidone

Prulifloxacin

Rufloxacin

Siltuximab

Simeprevir

Sparfloxacin

Temafloxacin

Tocophersolan

Tosufloxacin

Trovafloxacin Mesylate

Ulipristal

Vandetanib

Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Atenolol

Betaxolol

Bevantolol

Bisoprolol

Bitter Melon

Bucindolol

Carteolol

Carvedilol

Celiprolol

Cephalexin

Colesevelam

Dilevalol

Enalaprilat

Enalapril Maleate

Esmolol

Fenugreek

Glucomannan

Guar Gum

Iproniazid

Isocarboxazid

Labetalol

Levobunolol

Linezolid

Mepindolol

Methylene Blue

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Oxprenolol

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Psyllium

Ranolazine

Rasagiline

Rifampin

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Tranylcypromine

Trospium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol, excessive use or

Underactive adrenal glands or

Underactive pituitary gland or

Undernourished condition or

Weakened physical condition—These conditions could make you more sensitive to the effects of low blood sugar.

Alcoholism, history of or

Gallstones or

Hypertriglyceridemia (high triglycerides or fats in the blood)—May increase risk of having pancreatitis.

Anemia (low levels of red blood cells) or

Pancreatitis (inflammation and swelling of the pancreas) or

Vitamin B12 deficiency—Use with caution. May make these conditions worse.

Angioedema (swelling of the face, lips, tongue, or throat) to similar medicines (e.g., linagliptin, sitagliptin), history of—Use with caution. Patients who have experienced this condition may be at increased risk of getting angioedema with saxagliptin.

Congestive heart failure, acute or unstable or

Dehydration or

Heart attack, acute or

Hypoxemia (decreased oxygen in the blood) or

Kidney disease or

Liver disease or

Sepsis (severe infection) or

Shock (low blood pressure, blood circulation is poor)—A rare condition called lactic acidosis can occur. Talk with your doctor if you have concerns about this.

Diabetic ketoacidosis (ketones in the blood) or

Kidney disease, severe or

Liver disease, severe or

Metabolic acidosis (acid in the blood) or

Type I diabetes—Should not be used in patients with these conditions.

Fever or

Infection or

Surgery or

Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin.

Proper Use of This Medicine:

This medicine usually comes with a Medication Guide. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Saxagliptin and metformin combination should be taken with the evening meal to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

While taking the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):

For type 2 diabetes:

For patients taking metformin alone:

Adults—The metformin dose is the same as the dose you are already taking. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 milligrams (mg) of saxagliptin and 2000 mg of metformin once a day.

Children—Use and dose must be determined by your doctor.

For patients taking saxagliptin alone:

Adults—At first, one tablet containing 5 milligrams (mg) of saxagliptin and 500 mg of metformin once a day. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 5 mg of saxagliptin and 2000 mg of metformin once a day.

Children—Use and dose must be determined by your doctor.

For patients using 2.5 milligrams (mg) of saxagliptin and extended-release metformin together:

Adults—One tablet containing 2.5 mg of saxagliptin and 1000 mg of metformin once a day.

Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to temporarily stop taking this medicine before you have major surgery or diagnostic tests including procedures that use contrast dye.

Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include: abdominal or stomach discomfort; decreased appetite; diarrhea; fast or shallow breathing; a general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. These conditions may be life-threatening and require immediate medical attention. Stop using this medicine and check with your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

It is very important to carefully follow any instructions from your health care team about:

Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur with lifestyle changes, such as changes in exercise or diet. Furthermore, counseling on contraception and pregnancy may be needed, because of the problems that can occur in patients with diabetes during pregnancy.

Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and that lists all of your medicines.

Saxagliptin and metformin combination can cause low blood sugar. However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take saxagliptin and metformin combination with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your household should also know how to use it.

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

tightness in the chest

unusual bleeding or bruising

vomiting

wheezing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

muscle aches

stuffy nose

Less common

Abdominal or stomach pain

itching

pain or tenderness around the eyes and cheekbones

redness of the skin

weakness

welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.